Based on ISO 9001's process approach to quality management, ISO 13485 focuses on what the manufacturer does to deliver safe and effective medical devices. Regulatory authorities in most major markets (including the European Union, United States, Canada, Japan, and Taiwan) require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality management system in place. An ISO 13485-compliant system expedites access into those countries that require it.
GMCSPL has extensive, global experience in the medical industry, both in management systems certification and in product safety testing and certification. Our staff members have many years of industry experience, and they work directly with regulatory authorities to stay updated on the latest requirements - resulting in a wealth of knowledge that we are able to pass on to you.